FDA Device recall Z-2235-2024
Brand Name: Fathom Pedicle-Based Retractor Product Name: C/C Blade, 50-80mm Model/Catalog Number: MR2102050 Product Description: Cranial Ca…
- FDA Device
- Class II
- ongoing
- Published 2024-07-10
On 2024-07-10 the FDA classified a Class II recall of Brand Name: Fathom Pedicle-Based Retractor Product Name: C/C Blade, 50-80mm Model/Catalog Number: MR2102050 Product Description: Cranial Ca… by Seaspine Orthopedics, citing cranial Caudal Blades manufactured incorrectly could result in fracture and/or damage to the bone structure.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2235-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-05-17 |
| Published | 2024-07-10 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Seaspine Orthopedics |
| Distribution | US |
Product
Brand Name: Fathom Pedicle-Based Retractor Product Name: C/C Blade, 50-80mm Model/Catalog Number: MR2102050 Product Description: Cranial Caudal Blade Component: Yes, a component of a retractor blade
Reason
Cranial Caudal Blades manufactured incorrectly could result in fracture and/or damage to the bone structure
Identifiers
| code_info | UDI: 10889981300067 Lot Number: WT36299C |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
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Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2235-2024%22
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